Delhi HC Rejects Intra-Cellular Therapies' Patent Appeal, Holds Bioavailability Alone Insufficient

The Delhi High Court on 6 July upheld the order of the Controller of Patents and Designs dated 27 April 2023, which had rejected the patent application filed by Intra-Cellular Therapies Inc. for “Organic Compounds” on the ground that the claimed invention lacked novelty.

Justice Tushar Rao Gedela dismissed Intra-Cellular Therapies Inc.'s appeal against the rejection of its patent application for deuterated organic compounds used in treating psychiatric disorders, holding that the claimed invention lacked novelty. He observed:

"The enhanced bioavailability does not, by itself, lead to enhanced therapeutic efficacy, and the appellant has to show, with research data, that the improved bioavailability actually translates into a therapeutic benefit."

Intra-Cellular filed the patent application in September 2018 seeking protection for specific deuterated heterocycle-fused gamma-carbolines. It claimed that the compounds could be used for treating diseases associated with 5-HT2A receptors, serotonin transporter pathways and dopamine D1/D2 receptor signalling.

The claimed therapeutic applications included schizophrenia, psychosis, anxiety and sleep disorders. The Controller had rejected the application on the grounds of lack of novelty, absence of inventive steps and non-patentability.

The High Court observed that improved bioavailability alone could not establish enhanced therapeutic efficacy unless supported by research data demonstrating a corresponding therapeutic benefit. It held that the claimed invention did not satisfy the requirement of novelty.

Having upheld the objection relating to lack of novelty, the Bench held that it was not necessary to examine the objection concerning inventive steps. It concluded:

"The impugned order dated 27.04.2023 passed by the respondent, is upheld and the present appeal stands dismissed. No order as to costs.”

Accordingly, the High Court dismissed the appeal.